Cognitive strategy training in Post-COVID-19 Syndrome: A feasibility trial.

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Project Summary/Abstract The long-term goal of this project is to help improve recovery from cognitive impairment associated with post- COVID-19 syndrome (PCS). PCS cognitive symptoms require the rehabilitation community to investigate ways to: (1) reduce the functional impact of the symptoms on daily life and (2) support individuals with PCS to establish new habits to improve and maintain health. The research hypothesis is that an activity-based metacognitive-strategy training intervention, the Cognitive Orientation to daily Occupational Performance (CO- OP) approach can feasibly be administered remotely and will improve activity performance, cognitive function, and quality of life in individuals with PCS. The specific aims of this study are to assess the: (1) feasibility of delivering CO-OP remotely to individuals with PCS in preparation for a future R01 trial; and (2) effect of CO-OP on activity performance, subjective and objective cognitive function, and quality of life in a sample of individuals with PCS as compared to an inactive control group. Specific aims will be completed through a single-blind, parallel, exploratory, randomized controlled trial. Individuals with PCS will be identified and asked to complete a prescreening survey to evaluate eligibility. Those meeting eligibility will undergo a baseline assessment battery. Participants (n=65) will then be randomized to a remote CO-OP treatment group (45 minutes per week for 10 weeks) or to an inactive control group. A post-intervention assessment will be completed immediately following the intervention. The purpose of this R21 is to evaluate feasibility outcomes and to obtain estimates of effect and precision of response on the outcome measures. To explore the effects of dosage on the primary outcome of activity performance, the biweekly COPM ratings will be plotted against time. Independent samples t-test and chi square test will be used to investigate differences among the two study arms and to assess whether randomization was successful. Descriptive statistics will be calculated for demographic information and the measures of intervention acceptability. Pre-to-post change in each of the outcome measures will be calculated for both groups. Cohen’s d effect size reported with precision around the estimate, 95% confidence intervals, will be used to evaluate the within and between group effects of the interventions on the primary and secondary outcome measures. The expected outcomes of this study are: (1) data to support the feasibility of remotely administering CO-OP; and (2) data to estimate effect sizes and precision of estimates of the CO-OP intervention in PCS. These data will be important for planning a future clinical trial to confirm any effects. This proposal is timely and consistent with the research priority of the National Center for Medical Rehabilitation Research (NCMRR) to identify, prevent, and treat key secondary conditions (e.g. PCS); the research program area of chronic symptom management; and the NICHD Notice of Special Interest (NOT-HD-20-03) addressing rehabilitation needs of COVID-19 survivors.